Applications for Human Use

All of our standard (non-cGMP) products are intended for investigational use only.
Persons intending to use standard Omicron products in applications involving
human subjects assume the responsibility for these applications, and are required to
comply with appropriate regulations, guidelines and procedures. Regulatory agencies
should be consulted for pertinent information before conducting studies of this
type. In some instances, approval may need to be obtained from the U.S. Food
and Drug Administration (U.S-based studies) or from similar agencies in the
country where the studies are to be conducted. Omicron will supply supporting
information (general details of synthesis, analytical tests, etc.) to assist
groups in obtaining formal approval of their studies by these agencies. Upon
request, Omicron will ultrafilter products that are to be tested for
sterility and/or pyrogenicity for an extra fee. Persons intending to use our
products for in vivo applications, especially in humans, are advised
to have appropriate independent tests of the formulated and/or repackaged
product conducted by a qualified agent prior to usage. Omicron will work
on a confidential basis with groups conducting such tests.